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Personalized Pharmaco-Lifestyle Interventions for Severe Mental Illnesses (LIFETRAIN) (LIFETRAIN)

7 mai 2026 mis à jour par: Isabel Maurus, Ludwig-Maximilians - University of Munich

Personalised Pharmaco-Lifestyle Interventions for Severe Mental Illnesses Enhanced by Digital Health and Immersive Technologies

This randomized, rater-blind, multicenter clinical trial will evaluate whether a personalized pharmaco-lifestyle intervention improves mental functioning in adults with severe mental illness, including schizophrenia, bipolar disorder, or major depressive disorder. Participants will be randomized to either a modular individualized intervention program or a structured psychoeducation control condition. The individualized intervention may include physical exercise, an anti-inflammatory diet, sleep intervention, social prescribing, semaglutide for eligible participants with overweight or obesity, and optional closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms. The primary outcome is change in the SF-36 Mental Component Summary score from baseline to Month 3.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

140

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Allemagne
      • Mannheim, Allemagne, 68159
        • Central Institute of Mental Health
      • München, Allemagne, 80336
        • Department of Psychiatry and Psychotherapy, LMU Klinikum
  • L'Autriche
      • Vienna, L'Autriche, 1090
        • Medical University of Vienna
  • Pays-Bas
      • Groningen, Pays-Bas, 9713 GZ
        • University Medical Center Groningen
      • Utrecht, Pays-Bas, 3584 CX
        • University Medical Center Utrecht

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Age 18 to 65 years
  • Able and willing to provide written informed consent
  • Diagnosis of schizophrenia, bipolar disorder, or major depressive disorder according to DSM-5-TR, confirmed by M.I.N.I.
  • Female participants of childbearing potential must agree to use an effective method of contraception
  • Stable psychopathology defined as BPRS less than or equal to 41, MADRS less than or equal to 34, and YMRS less than or equal to 25, with stable psychopharmacological treatment for at least 2 weeks
  • Reduced functioning at screening defined as SF-36 score less than or equal to 40
  • If using benzodiazepines, dose less than or equal to 2 mg lorazepam equivalent per day
  • Stable somatic condition for at least 4 weeks
  • For semaglutide treatment: overweight with BMI at least 27 and less than 30 kg/m² plus at least one weight-related risk condition, or obesity with BMI at least 30 kg/m²
  • For optional adaptive neurostimulation: MADRS score at least 19
  • Expected ability to comply with study procedures in the investigator's judgment

Exclusion Criteria:

  • Unable to provide informed consent
  • Current or past neurological disorder or structural brain pathology that may affect study procedures
  • Known intolerance or hypersensitivity to semaglutide
  • Pregnancy or lactation
  • Serious suicidal risk
  • Substance dependence within the last 3 months
  • BMI less than 18.5 kg/m²
  • eGFR less than 30 mL/min/1.73 m²
  • Type 1 diabetes, diabetic ketoacidosis, diabetic retinopathy, or poorly controlled diabetes with recurrent hypoglycemic episodes
  • Pancreatitis, history of pancreatitis, or pancreatic cancer
  • Multiple endocrine neoplasia type 2 or personal/family history of medullary thyroid cancer
  • Pre-existing significant gastrointestinal conditions such as inflammatory bowel disease or gastroparesis
  • Need for acute surgery
  • Other medical condition that may affect study procedures or participant safety
  • For optional adaptive neurostimulation: nonremovable metal in or around the head, known increased intracranial pressure due to infarcts or trauma, professional metal work or prior ocular metal injury, history of rTMS or ECT, or current (es)ketamine treatment

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Personalized pharmaco-lifestyle intervention
Participants receive one or more individualized intervention modules selected according to predefined eligibility criteria, digital guidance, and shared decision-making. Modules may include exercise, anti-inflammatory diet, sleep intervention, social prescribing, semaglutide, and optional closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms. Weekly guided support is provided through Month 3, followed by self-directed continuation with digital support through Month 6.
Médicament: Semaglutide (SEMA)
Once-weekly subcutaneous semaglutide for eligible participants with overweight or obesity and metabolic risk, titrated according to protocol up to 2.4 mg/week as tolerated, followed by tapering after Month 6.
Comportemental: Exercise module
Personalized moderate-intensity exercise intervention with supervised sessions during the structured phase and supported maintenance, targeting at least 150 minutes of moderate physical activity per week.
Comportemental: Anti-inflammatory diet module
Structured anti-inflammatory dietary intervention based on the Brain Anti-Inflammatory Nutrition (BrAIN) diet, supported by coaching, recipes, and digital materials.
Comportemental: Sleep intervention module
Adapted cognitive behavioral therapy for insomnia (SLEEPexpert) including a structured introduction and supported self-management.
Comportemental: Social prescribing module
Structured intervention to increase social participation, community engagement, and behavioral activation.
Dispositif: Closed-loop transcranial alternating current stimulation (CL-tACS)
Optional adjunctive bifrontal closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms.
Comparateur actif: Structured lifestyle psychoeducation control
Participants receive structured psychoeducation and counseling on exercise, diet, sleep, and social contact approximately every four weeks through Month 3, followed by self-guided continuation through Month 6. Participants with prominent depressive symptoms may receive sham closed-loop transcranial alternating current stimulation.
Comportemental: Structured lifestyle psychoeducation
Control intervention consisting of psychoeducation and counseling on lifestyle domains with self-guided continuation.
Dispositif: Sham CL-tACS
Sham closed-loop transcranial alternating current stimulation in the control arm for eligible participants with prominent depressive symptoms.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Short Form 36 Health Survey (SF-36) Mental Component Summary (MCS) score
Délai: Baseline to Month 3
Change from baseline in the SF-36 Mental Component Summary score.
Baseline to Month 3

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Short Form 36 Health Survey (SF-36) Mental Component Summary score (MCS) at Month 6
Délai: Baseline to Month 6
Baseline to Month 6
Change in Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) score
Délai: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in Short Form 36 Health Survey (SF-36) total score
Délai: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in MATRICS Consensus Cognitive Battery
Délai: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in Insomnia Severity Index (ISI)
Délai: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in UCLA Loneliness Scale score
Délai: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in International Physical Activity Questionnaire
Délai: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in EQ-5D-3L score
Délai: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Incidence of adverse events and serious adverse events
Délai: Baseline through day 240-243
Baseline through day 240-243
Change in Brief Psychiatric Rating Scale (BPRS) psychotic symptoms
Délai: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in Montgomery-Åsberg Depression Rating Scale (MADRS)
Délai: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in Young Mania Rating Scale (YMRS)
Délai: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in Pittsburgh Sleep Quality Index (PSQI) scores
Délai: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in step aerobic test performance
Délai: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in grip strength
Délai: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in body weight
Délai: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in body mass index (BMI)
Délai: Baseline to Month 3 and Month 6
Weight and height will be combined to report BMI in kg/m^2
Baseline to Month 3 and Month 6
Change in waist-to-hip ratio
Délai: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Chage in blood pressure
Délai: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in lean mass
Délai: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in fat mass
Délai: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ludwig-Maximilians - University of Munich

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2028

Achèvement primaire (Estimé)

1 juillet 2030

Achèvement de l'étude (Estimé)

1 décembre 2030

Dates d'inscription aux études

Première soumission

9 avril 2026

Première soumission répondant aux critères de contrôle qualité

7 mai 2026

Première publication (Réel)

14 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • LIFETRAIN
  • U1111-1340-3272 (Autre identifiant: Universal Trial Number (UTN))

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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